Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Intervention Study to Examine the Effectiveness of Lifestyle Counseling Using the "Stage of Change" Model Versus Conventional Physical Therapy on Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631344
• Other study ID #: 2008036
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: January 8, 2019

Study information

• Verified date: January 2019
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background:

Low back pain is the leading cause of disability, affecting the quality of life and work productivity.

It is the most common reason for seek medical help and advice. Low back pain creates huge economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically defined with no preferred medical treatment

1. Study objectives:

To prove that consulting using the "Stage of change" model for daily physical activity will lead to long term improvement of pain, disability and well-being parameters of those suffering from chronic low back pain, people age 25-55, when compared to conventional Physical Therapy.

2. Study hypotheses:

The intervention groups vs. Physical Therapy group will demonstrate that the following parameters will improve after: 3 months, one, two and five years.

1. Pain reduction.

2. Less disability - improvement in daily activities.

3. Better feeling of health and well-being.

4. Increased and better compliance to daily sport activities.

5. BMI reduction.

6. Reduction of cigarette smoking.

7. Reduction of usage of anti-analgesics and anti-inflammatory medications.

8. Reduction in number of visits to Physical Therapy clinics due to low back pain.

3. Methods:

The present Randomized intervention study that will include 220 healthy individuals, males and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or without radiation to the legs that were referred to Maccabi Healthcare Services Physical Therapy clinics in the Sharon district in Israel.

These individuals will be randomized to one of the following two groups:

1. Conventional Physical Therapy.

2. Physical Therapy focused on healthy lifestyle using the "Stage of Change" model.

Non-dependent observer will follow-up on the outcome parameters via phone calls and filling the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 8, 2019
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• Men and women

• Age 25-55 years old

• Chronic / recurrent low back pain (over 3 months)

• With or without radiation

Exclusion Criteria:

• Rheumatoid disease

• Tumors

• Fibromyalgia

• Back surgery

• Road / work accidents

• Non Hebrew speaking

• Pregnancy

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Daily physical activity consultation, Using the "Stage of change" model
Consultation of daily physical activity is provided, including selection of up to four pain relief exercises

Locations

Country	Name	City	State
Israel	Maccabi Healthcare Services Clinics	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years		3 months, 1, 2 and 5 years
Secondary	Change from baseline of Pain using the Numerical pain scale at 3 months, 1, 2 and 5 years		3 months, 1, 2 and 5 years